NCT03888248

Whole-body Vibration in Children With Neurofibromatosis Type 1

Completed NA Last updated 16 March 2021

What this trial tests

NA trial testing Whole-body vibration in Neurofibromatosis Type 1 in 30 participants. Completed in 30 November 2020.

Timeline

22 July 2019

Primary endpoint
30 November 2020

30 November 2020

Quick facts

Lead sponsor	Manchester University NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	22 July 2019
Primary completion	30 November 2020
Estimated completion	30 November 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Whole-body vibration
• Muscle strengthening exercises

Conditions studied

• Neurofibromatosis Type 1 — all drugs for Neurofibromatosis Type 1 →
• Muscle Weakness — all drugs for Muscle Weakness →

Sponsor

Manchester University NHS Foundation Trust

Who can join

Adults 6 to 16, any sex, with Neurofibromatosis Type 1 or Muscle Weakness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is known that children with NF1 can have weak muscles and suffer from tiredness. It is also known that in similar conditions affecting children's muscles, standing on a vibration device for a few minutes each day can strengthen muscles and improve their ability to perform day-to-day activities. The investigators believe this vibrating platform can be used to strengthen the muscles of children with NF1 also, beyond standard exercises, and therefore allow them to perform day-to-day activities better, do more activity and feel less tired.

If families are keen to take part in this study, the investigators will first need to check they are suitable for the trial. This will be based on the participant's age (6-16 years), their other medical problems that would affect use of the vibration device or tests to assess how effective it is, and their level of muscle weakness.

Once families have agreed to take part, participants will be randomised either to receive a muscle-strengthening exercise session delivered by a physiotherapist that children with weak muscles should continue to perform daily for the next 6 months; or to receive a vibration device to take home and use for a few minutes 5 days a week for 6 months as well as the exercises.

All participants will be invited to attend for a variety of activities and tests, just before starting the trial and 6 months later at the end of the trial to see if there is any benefit from the vibration device. The investigators will repeat these tests again 3 months later, to see if any benefits observed remain, even after the device is removed. They will involve jumping, hopping and balancing on a board, gripping a machine as hard and as long as possible, being fitted with a device that measures activity for 7 days, walking as far as possible for 6 minutes, scanning muscles using MRI, completing a tiredness and general well-being questionnaires, and parents completing a questionnaire of the participant's attention and intellect. The jumping will also be performed 3 months into the study, to see if there is any early improvement in this key test.

All participants will be given full details of what the trial involves before taking part. As with any other trial, participants and their families are free to stop taking part at any time. Although the investigators do not anticipate any safety issues, if any do arise, the families will be asked to contact the trial team.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The skeletal muscle phenotype of children with Neurofibromatosis Type 1 - A clinical perspective.
   Chinoy A, Vassallo GR, Burkitt Wright E, Eelloo J, et al · · 2022 · cited 1× · PMID 35234161